Qa Spec-Root Cause Analysis-Control Charting-3Rd

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of Company’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Requisitos:
Minimum 5 years of experience in GMP regulated industry. Experience in Root Cause Analysis (Fishbone, 5 Why’s, Kepner Tregoe). Biotechnology industry experience. Knowledge of control charting. Project management skills. Availability to support non-standard shift. Bachelor Degree in Science or Engineering Completed. Fully bilingual. Qualified candidates please send resume to: **********